This mdr is result of a retrospective review of complaints.Based on the initial escalation analysis, the sensor performance would recover in the next few days (at the time) and the sensor diagnostics did not indicate a failure.The user was given the option to either continue with using the system or receiving a sensor replacement.The user opted to have the sensor replaced and therefore the rma was created for the sensor (b)(4).Upon receipt of the rma, the sensor was tested in-house, and the review of qc data did not reveal any malfunction of the sensor.As part of resolution, the rma was authorized to offer the user a sensor replacement.
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